Tag Archives: Amphastar

In a decision issued August 3, 2012 in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the Federal Circuit held that the safe harbor provisions of 35 USC § 271(e)(1) can shield the defendants from liability for patent infringement arising out of their use of patented methods to satisfy FDA testing requirements for their approved products. Judge Moore wrote the opinion for the court, which was joined by Judge Dyk. Chief Judge Rader wrote a dissenting opinion, explaining his contrary view and asserting that the majority decision is in direct conflict with the court’s August 2011 decision in Classen Immunotherapies, Inc. v. Biogen Idec. Chief Judge Rader was in the majority in that decision, while Judge Moore dissented. A petition for certiorari in Classen is pending at the Supreme Court, and it is likely that the Supreme Court will have to resolve these conflicting views of the safe harbor. Continue reading this entry